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Important Safety Information

Ozempic® Pen

Semaglutide injection

Boxed Warning

Boxed Warning: Risk of thyroid C-cell tumors

Ozempic (semaglutide) causes thyroid C-cell tumors in rodents at clinically relevant exposures. It is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans. Ozempic is contraindicated in patients with a personal or family history of MTC and in patients with MEN 2.

About this product

Ozempic® (semaglutide) injection is FDA-approved to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease. Use for weight loss is off-label and is at the discretion of your prescribing provider.

Indication

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or overweight in the presence of at least one weight-related condition.

Important safety information

Semaglutide may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
  • Inflammation of the pancreas (pancreatitis). Stop using and call your provider immediately if you have severe pain in your stomach area that does not go away, with or without vomiting.
  • Gallbladder problems, including gallstones. Tell your provider if you have pain in your upper stomach, fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
  • Low blood sugar (hypoglycemia), especially if used with insulin or sulfonylureas.
  • Kidney problems (kidney failure). Severe nausea, vomiting, or diarrhea may lead to dehydration.
  • Serious allergic reactions. Stop using and get medical help right away if you have swelling of your face, lips, tongue, or throat, problems breathing, severe rash or itching, fainting, or very rapid heartbeat.
  • Change in vision in people with type 2 diabetes.
  • Increased heart rate.
  • Depression or thoughts of suicide. Call your provider right away if you have any mental changes, especially sudden ones.

Do not use semaglutide if you

  • Or any of your family members have ever had medullary thyroid carcinoma (MTC).
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Have had a serious allergic reaction to semaglutide or any of the ingredients.

Most common side effects

The most common side effects of semaglutide may include:

  • Nausea, diarrhea, vomiting, constipation
  • Stomach (abdominal) pain
  • Headache, fatigue
  • Dyspepsia (indigestion), dizziness
  • Bloating, belching, flatulence (gas)
  • Stomach flu (gastroenteritis), heartburn (gastroesophageal reflux disease)

Before starting semaglutide, tell your provider if you

  • Have or have had problems with your pancreas, kidneys, or liver
  • Have type 2 diabetes and a history of diabetic retinopathy
  • Have or have had depression, suicidal thoughts, or mental health issues
  • Are pregnant, plan to become pregnant, or are breastfeeding — semaglutide may harm an unborn baby. Stop semaglutide at least 2 months before a planned pregnancy.
  • Are taking other prescription medications, over-the-counter drugs, vitamins, or herbal supplements — semaglutide slows stomach emptying and can affect how other oral medications are absorbed.

Reporting side effects

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the manufacturer or to your NowYou care team.

Important

This summary does not include all information about this medication. It is not a substitute for the full Prescribing Information or for talking with your healthcare provider. Please read the full Prescribing Information and Medication Guide before starting treatment, and discuss any questions with your provider.

Full prescribing information

Always read the full Prescribing Information and Medication Guide before starting treatment.

This safety summary is provided for educational purposes and does not replace the full Prescribing Information, Medication Guide, or professional medical advice. Always discuss benefits, risks, and alternatives with your licensed provider.